The Pharma Data

JULY 2, 2025

Biogen Launches Global Phase 3 PROMINENT Trial Evaluating Felzartamab in Primary Membranous Nephropathy Biogen Inc. The trial is expected to complete in 2029. This randomized, open-label study will compare felzartamab with tacrolimus, a commonly used immunosuppressant, in a cohort of approximately 180 patients worldwide.

Trials

Drug Target Review

MARCH 17, 2025

Neuropsychiatric treatment is on the verge of a major transformation. Historically, treatment options have been limited, with patients relying on daily medications that have minimal efficacy and troublesome side effects. “Zelquistinel is a positive modulator of NMDA receptors,” Donello explains.

Treatment

Drug Target Review

JULY 29, 2025

Effective financial management is a cornerstone in the success of clinical trials, which are integral to the advancement of drug discovery. As the pharmaceutical and biotech industries continue to evolve, clinical trials become more complex, and the importance of robust financial oversight has never been clearer.

Clinical Trials

The Pharma Data

AUGUST 1, 2025

The agreement centers around the investigational RNA interference (RNAi) therapy, plozasiran, which targets apolipoprotein C-III (APOC3) and is under development for the treatment of familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG). Europe, and elsewhere. The application was formally accepted in January 2025.

Licensing

Drug Target Review

DECEMBER 11, 2024

However, this method isn’t universally applicable, as some matrices may not be compatible with charcoal treatment due to their specific composition or the nature of the analytes involved. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.

International

The Pharma Data

JUNE 24, 2025

For Revolution Medicines, the funding not only provides critical financial runway but also preserves full strategic autonomy—a rare combination in the biotechnology landscape where promising young companies often trade developmental control for capital through licensing or acquisition. Source link

Drug Development

Drug Target Review

MARCH 4, 2025

Obesity treatment is undergoing a major shift, much like the advances seen in cancer care. Phenomix Sciences , led by CEO Mark Bagnall, is using precision medicine to make treatments more targeted and effective. Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach.

Therapies

BioPharma Drive: Drug Pricing

JULY 8, 2025

Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Though it may not be used across a broader patient population, results from Arvinas and Pfizer’s trial of vepdegestrant offer some validation for degraders’ potential. But hurdles remain.

Targeted Protein Degradation

The Pharma Data

JUNE 15, 2025

The data, which encompass up to 3 years of follow-up after a single infusion of the treatment, were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held from June 13–16 in Glasgow, United Kingdom. President and Chief Executive Officer of Intellia Therapeutics.

Treatment

BioPharma Drive: Drug Pricing

AUGUST 13, 2025

13, 2025 Ned Pagliarulo Lead Editor post share post print email license B cells, like those pictured above, malfunction in autoimmune diseases. 13, 2025 Ned Pagliarulo Lead Editor post share post print email license B cells, like those pictured above, malfunction in autoimmune diseases. Published Aug. Published Aug.

Licensing

New Drug Approvals

MAY 17, 2025

Tofersen , sold under the brand name Qalsody , is a medication used for the treatment of amyotrophic lateral sclerosis (ALS). [3] Jump up to: a b c d e f g h i j k l “FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene” (Press release). 25 April 2023. Retrieved 10 June 2023.

FDA Approval

Broad Institute

OCTOBER 29, 2024

Importantly, unlike other MCL1 inhibitors that have raised concerns about cardiovascular side effects in early-stage clinical trials, BRD-810 acts quickly within cancer cells and is eliminated from the body in animal models within a few hours. This rapid clearance minimizes the drug’s potential impact on healthy cells. Nature Cancer.

Drugs

New Drug Approvals

JULY 25, 2025

Vamorolone , sold under the brand name Agamree , is a synthetic corticosteroid , which is used for the treatment of Duchenne muscular dystrophy. [4] In December 2023, it was approved in the EU for the treatment of patients ≥4 years of age. Treatment of crude 9.3 4] [5] [6] [7] [8] It is taken by mouth. [1] Shale, U.J.

FDA

New Drug Approvals

APRIL 11, 2025

2] The label also has a warning about liver toxicity and the need to monitor liver blood tests at baseline and then monthly for at least six months after initiating treatment with fitusiran or after a dose increase of fitusiran. [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1] 26 March 2025.

Clinical Trials

New Drug Approvals

MAY 9, 2025

1] History The efficacy of elacestrant was evaluated in the EMERALD trial, which was a randomized, open-label, active-controlled, multicenter study involving 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer. 1] [4] It is taken by mouth. [1] 3] [7] PATENTS Cruskie MP, et al. 8 February 2023.

FDA

New Drug Approvals

JUNE 11, 2025

4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4]

FDA

The Pharma Data

JUNE 24, 2025

This could make it a transformative therapeutic option for a wide range of cancers that currently have few, if any, effective targeted treatments. As the Phase 3 programs progress and further clinical data emerge, all eyes will be on daraxonrasib and Revolution Medicines’ broader RAS(ON) inhibitor portfolio.

Clinical Development

Broad Institute

MAY 21, 2025

The work of June, Levine, Rivire, and Sadelain laid the foundation for a whole new class of treatments. In the early 2000s, both teams began preparing for clinical trials. After their clinical results, their technology was licensed to Juno Therapeutics (later acquired by Bristol Myers Squibb.)

Therapies

BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Takeda reported positive results for oveporexton, a drug being developed for narcolepsy Type 1, on July 14, 2025. You can unsubscribe at anytime. Oveporexton’s safety profile was “consistent” with what’s been observed in previous clinical tests, Takeda said.

Drugs

New Drug Approvals

APRIL 25, 2025

8] Therefore, it may serve as a new addition to combination therapy with conventional cancer treatment, such as chemotherapy. Combining inavolisib with palbociclib and fulvestrant might improve treatment of breast cancer. [14] 2] [3] It is an inhibitor and degrader of mutant phosphatidylinositol 3-kinase (PI3K) alpha. [4] Hz, 1H), 5.02-4.89

FDA

New Drug Approvals

APRIL 2, 2025

2] Medical uses Suzetrigine is indicated for the treatment of moderate to severe acute pain in adults. [1] The FDA has long supported development of non-opioid pain treatment. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo. Suzetrigine is taken by mouth. [1]

FDA

The Pharma Data

JUNE 24, 2025

We look forward to this strategic alliance continuing to expand the frontiers of cutting-edge science and translating groundbreaking discoveries into transformative treatments for patients.” The company currently operates two global research and development (R&D) centers and four world-class production facilities across China.

Pharma R&D

DrugBank

JUNE 18, 2025

The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance. Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations.

Drug Development

The Pharma Data

JULY 2, 2025

This marks a pivotal moment for the treatment of a rare and aggressive group of cancers—including gallbladder cancer (GBC) and cholangiocarcinoma (CCA)—which are often diagnosed at an advanced stage when curative surgical options are no longer feasible. under license from Zymeworks Inc. , formerly BeiGene, Ltd.) the original developer.

Therapies

New Drug Approvals

AUGUST 14, 2025

FDA Approval of Modeyso (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma” (Press release). 1] [2] Dordaviprone is a protease activator of the mitochondrial caseinolytic protease P. [1] 3] Dordaviprone was approved for medical use in the United States in August 2025. [2] 2020.09.005.

Clinical Trials

New Drug Approvals

JUNE 29, 2025

Medical uses Taletrectinib is indicated for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. [1] Medical uses Taletrectinib is indicated for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. [1] 1] It is taken by mouth. [1]

International

New Drug Approvals

JUNE 15, 2025

Its sodium salt is used for the treatment of generalised myasthenia gravis (a disease that leads to muscle weakness and tiredness) in adults whose immune system produces antibodies against acetylcholine receptors. . 6] [9] [10] It is a complement inhibitor that is injected subcutaneously (under the skin). [6] April 2018). 90 (15 Supplement).

FDA

New Drug Approvals

JULY 10, 2025

g/mol O5ZD2TU2B7 FDA 7/3/2025, Ekterly, To treat acute attacks of hereditary angioedema N -[(3-fluoro-4-methoxypyridin-2-yl)methyl]-3-(methoxymethyl)-1-[[4-[(2-oxopyridin-1-yl)methyl]phenyl]methyl]pyrazole-4-carboxamide Sebetralstat , sold under the brand name Ekterly , is a medication used for the treatment of hereditary angioedema. [1]

FDA

New Drug Approvals

MAY 8, 2025

1] [11] In December 2023, the US Food and Drug Administration (FDA) expanded the indication for pirtobrutinib to include the treatment of adults with chronic lymphocytic leukemia or small lymphocytic leukemia. [7] 7] [12] In the European Union, pirtobrutinib is indicated for the treatment of mantle cell lymphoma. [2] 27 January 2023.

FDA Approval

New Drug Approvals

APRIL 18, 2025

Formula C 27 H 29 Cl 2 FN 2 OS Crinecerfont , sold under the brand name Crenessity , is a medication used for the treatment of congenital adrenal hyperplasia. [1] 2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2] 321839-75-2 Molecular Weight 519.50 1 December 2024.

FDA

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials. You can unsubscribe at anytime.

FDA

The Pharma Data

JULY 2, 2025

FDA Grants Priority Review to Merck’s WINREVAIR™ Based on Landmark ZENITH Trial Showing Dramatic Reduction in Morbidity and Mortality in PAH Patients Merck (NYSE: MRK), operating as MSD outside the U.S. label of WINREVAIR based on compelling new evidence from the Phase 3 ZENITH trial. risk score of 9 or greater.

Trials

New Drug Approvals

MAY 15, 2025

5] [7] [8] It is the first approved medication for the treatment of activated PI3K delta syndrome. [5] 5] [7] [8] It is the first approved medication for the treatment of activated PI3K delta syndrome. [5] 2] [5] It is a kinase inhibitor [2] [6] that is taken by mouth. [2] mmol) in CH 2 CI 2 (100 mL), was added TFA (41.8 24 March 2023.

FDA Approval

SugarCone Biotech

JULY 6, 2025

HER3 plays a pivotal role in activating downstream signaling pathways through heterodimerization with other receptors like HER2 and can mediate resistance to therapies targeting EGFR and HER2, making it a compelling target for novel treatments in cancers that rely on oncogenic signaling via those related growth factor receptors.

Drug Development

New Drug Approvals

APRIL 19, 2025

This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. 9] It is used as landiolol hydrochloride. IV -Blocker max.

FDA

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. Data from that trial is expected in 2027. “I and European drugmakers.

Disease

New Drug Approvals

JULY 7, 2025

1] Pimicotinib is under investigation in clinical trial NCT05804045 (Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)). History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] 6] The U.S. 6] The U.S.

Small Molecule